- Determine the duration of survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive high-dose methotrexate IV over 4 hours on day 1 and oral or IV leucovorin
calcium every 6 hours beginning on day 2 and continuing until blood methotrexate levels are
acceptable. Treatment repeats every 14 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients then receive standard radiotherapy with or without chemotherapy. Patients with
disease progression proceed to standard radiotherapy with or without chemotherapy upon
stopping methotrexate therapy.

Patients are followed at 30 days and then every 2 months for up to 2 years.

PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme (GBM)

- Supratentorial grade IV disease

- Measurable and contrast-enhancing disease ≥ 1 cm by CT scan or MRI

- No radiographic evidence of ascites or pleural effusion

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- SGOT ≤ 4.0 times upper limit of normal

- Bilirubin ≤ 2.0 mg/dL

Renal

- Creatinine ≤ 2.0 mg/dL

- Creatinine clearance ≥ 50 mL/min

Cardiovascular

- No uncontrolled hypertension

- No unstable angina

- No symptomatic congestive heart failure

- No uncontrolled cardiac arrhythmia

- No myocardial infarction within the past 6 months

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to achieve hydration

- No diabetes insipidus

- No known hypersensitivity to methotrexate or leucovorin calcium

- No concurrent serious infection or medical illness that would preclude study
participation

- No other malignancy within the past 2 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy for GBM

- No prior administration of any of the following biologic agents for GBM:

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